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Development of a small molecule inhibitor of PAI-1 for the treatment of diffuse cutaneous systemic sclerosis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44AR074318-02
Agency Tracking Number: R44AR074318
Amount: $746,985.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAMS
Solicitation Number: PA18-574
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-01
Award End Date (Contract End Date): 2021-08-31
Small Business Information
46430 PEARY CT, Novi, MI, 48377-1732
DUNS: 080325522
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 JAMES HARTMAN
 (303) 817-7690
 hartmanc55@gmail.com
Business Contact
 STEPHEN BENOIT
Phone: (269) 370-0775
Email: sbenoit@mditherapeutics.com
Research Institution
N/A
Abstract
This project will provide critical preclinical data for a novel therapeutic small molecule inhibitor of plasminogen activator inhibitorPAIas a potential treatment for diffuse cutaneous systemic sclerosis with associated interstitial lung diseasedcSSc ILDSSc is a devastating disease of unknown etiology with no currently approved disease modifying treatmentslung fibrosisinterstitial lung diseaseILDis the leading cause of mortality in dcSScIn this phase II application we will further develop a highly innovative first in class therapeuticMDIPAIis the physiologic inhibitor of tissue and urokinase plasminogen activatortPA and uPAIn normal physiology PAIregulates processes such as fibrinolysis and wound healingHoweverelevated expression of PAIis associated with fibrotic diseases of the lungkidneyheartand importantly for this applicationwith SScThis association has led to the recognition that PAIcontributes directly to pathologyand that its inhibition may be an effective approach to treat fibrotic diseaseMDI Therapeutics has identified a highly effectiveorally activesmall molecule inhibitor of PAIwith efficacy in multiple models of fibrotic diseaseincluding pulmonary fibrosis and SScThe studies described in this Phase II application will provide critical safety and toxicology data as well as in vivo comparator studies with current treatment optionsThere are two Specific Aims with clearly defined Milestones aimed at advancing MDItoward filing an Investigational New DrugINDapplication and subsequently conducting first in human Phaseclinical studies which will be funded in Phase III by securing private venture capital investment Systemic sclerosis or scleroderma is a deadly disease of unknown etiology that has no cureWe will perform preclinical experiments to evaluate a new unique drug candidate for use as a novel scleroderma therapy

* Information listed above is at the time of submission. *

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